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The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214 in medically stable elderly subjects following multiple oral doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | TC-5214 |
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| 2 | Placebo Comparator | Placebo matched to TC-5214 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5214 | Drug | Tablet 1, 2, or 4 mg of TC-5213 will be given twice daily for 4 days and once on the 5th day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Range of 5 days | |
| Neurological examinations | Range of 5 days | |
| Visual acuity tests | Range of 5 days | |
| Vital signs | Range of 5 days | |
| Physical examinations | Range of 5 days | |
| Laboratory parameters | Range of 5 days | |
| Suicidality as assessed by the Columbia-Suicide Severity Rating Scale | Range of 5 days | |
| Electrocardiograms | Range of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables of TC-5214 by assessment of drug concentrations in plasma | Range of 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans A Eriksson, MD | AstraZeneca | Study Director |
| Wolfgang Kuhn, MD | Quintiles Phase 1 | Principal Investigator |
| Aslak Rautio, MD | Quintiles Hermelinen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Uppsala County | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24408516 | Derived | Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16. |
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| Placebo | Drug | Two subjects in each cohort will be given placebo. |
|